Search Results Summary:
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P1.1 Listing fixed-dose combination products
To inform a cost-minimisation approach, demonstrate equivalence (or noninferiority) of the combination product to its component medicines. If using a cost-minimisation approach, the pricing
of a combination product would normally be no greater than the sum of its individual components (at the current price to pharmacy level for PBS products or at the price to the Australian Government for NIP products
pbac.pbs.gov.au/product-type-1/p1.1_listing_fixed-dose_combination_products.html
Page last updated: September 2016
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Forms
The PB11a is a form that sponsors need to submit to reflect the listing price sought for their product on the Pharmaceutical Benefits Scheme (PBS) or when requesting a price or related alteration
Submit the PB11b form to the PBAC Secretariat at the time of making a PBAC submission, or to apply for a price increase for a product already listed on the PBS, submit to the Pricing Section.
pbac.pbs.gov.au/information/forms.html
Page last updated: September 2016
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1.4 Proposed PBS listing
Word the restriction to identify the use that should eventuate, and be consistent with TGA-approved indications (and other sections of the product information). Restrictions may increase
on the MBS, or the MBS item descriptor needs amending to permit use with the proposed medicine, a material codependency may exist (refer to Part B, Product type 4).
pbac.pbs.gov.au/section-1/1-4-proposed-pbs-listing.html
Page last updated: September 2016
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P3.4 Budgetary implications (Section 4)
for primary vaccination program. Where the proposed vaccine is to replace an existing product, estimate the extent of use based on data from current estimates of vaccinated cohorts. Where the proposed vaccine
Additional Information Requests Estimate financial implications using the basis for pricing that applies to the NIP or the PBS, as relevant (Subsection 4.4)Estimate extent of use and costs
pbac.pbs.gov.au/product-type-3/p3-4-budgetary-implications-section-4.html
Page last updated: September 2016
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4.2 Estimation of use and financial impact of the proposed medicine
Where these prices do not apply (eg for products to be funded under the National Immunisation Program [NIP]), apply the price to the Australian Government.
For these calculations, use constant prices, make no allowance for inflation and use a zero discount rate. See the Manual of resource items and their associated costs for further guidance.
pbac.pbs.gov.au/section-4/4-2-estimation-of-use-and-financial-impact-of-the-proposed-medicine.html
Page last updated: September 2016
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3B.3 Additional costs and/or cost offsets
product information to support a claim that monitoring costs are reduced.
If the proposed medicine is demonstrated to be no worse in terms of effectiveness, but to have a superior safety profile to the main comparator, a price advantage for the proposed medicine
pbac.pbs.gov.au/section-3b/3b-3-additional-costs-and-or-cost-offsets.html
Page last updated: September 2016
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3A.1 Overview and rationale of the economic evaluation
, particularly in the context of the Australian health care system where individuals do not face market prices. A cost-benefit analysis should not be presented as the primary analysis. The PBAC is unlikely
Include codependent diagnostic decisions and outcomes, if relevant (see Product type 4).
pbac.pbs.gov.au/section-3a/3a-1-overview-and-rationale-of-economic-evaluation.html
Page last updated: September 2016
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3A.6 Health care resource use and costs
Allocation of prices (unit costs) to resources
Present all unit prices and costs in Australian dollars with a consistent year of analysis (which should be stated and be as close as possible to the submission date).
pbac.pbs.gov.au/section-3a/3a-6-health-care-resource-use-and-costs.html
Page last updated: September 2016
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3B.4 Results
Consult the PBS Pricing Section , if necessary, for help in calculating medicine prices (ex-manufacturer and dispensed) from equi-effective doses. The economic claim should be that, at the price
pbac.pbs.gov.au/section-3b/3b-4-results.html
Page last updated: September 2016
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Abbreviations and acronyms
Abbreviations and acronyms TermDefinition CEAcost-effectiveness analysis CIconfidence interval CUAcost-utility analysis DPMAdispensed price for maximum amount DPMQdispensed price for maximum quantity
pbac.pbs.gov.au/information/abbreviations-acronyms.html
Page last updated: September 2016
